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. 2016 Mar 21;2016(3):CD009645. doi: 10.1002/14651858.CD009645.pub3

Khedr 2013.

Methods Study design: RCT (parallel assignment)
Dropouts: none
Adverse effects: none
Deaths: none
ITT: yes, all participants completed the study
Participants Country: Egypt
Number of participants: 40 outpatients
Age: (mean ± SD) years
Gender: 14 females (35%)
Type of stroke: acute single thromboembolic non‐haemorrhagic infarction, documented by MRI
Time poststroke: (mean ± SD) 17.1 ± 3.6 days
Severity: (range) 7 to 13 on NIHSS
Exclusion criteria: extensive infarction (all territories of MCA), severe flaccid hemiplegia, head injury, neurological disease other than stroke, renal or hepatic impairment, previous administration of tranquilliser, inability to give informed consent, no MEP recorded from FDI muscle of the affected hand
Interventions 3 arms:
  1. A‐tDCS, 25 minutes at 2 mA daily for 6 consecutive days on M1 of the lesioned hemisphere, delivered by saline‐soaked pads (5 × 7 cm)

  2. C‐tDCS, 25 minutes at 2 mA daily for 6 consecutive days on M1 of the non‐lesioned hemisphere, delivered by saline‐soaked pads (5 × 7 cm)

  3. Sham tDCS, 25 minutes daily (with a short ramp‐up and ramp‐down of the current at the beginning and at the end of each session) for 6 consecutive days on M1 of the lesioned hemisphere

Outcomes
  1. NIHSS at baseline, at the end of the intervention period and at 1, 2 and 3‐month follow‐up (0 to 42, with higher scores indicating a more severe stroke)

  2. OMCASS at baseline, at the end of the intervention period and at 1, 2 and 3‐month follow‐up (0 to 100, with higher scores indicating no clinical impairment due to stroke)

  3. BI at baseline, at the end of the intervention period and at 1, 2 and 3‐month follow‐up (0 to 100, with higher scores indicating better global function)

  4. Muscle strength according to MRC at the end of the intervention period, at 1, 2 and 3‐month follow‐up (0 to 5, with higher scores indicating higher muscle strength)

  5. Cortical excitability (as measured by RMT and AMT) at the end of the intervention period, at 1, 2 and 3‐month follow‐up (with greater intensity indicating a higher threshold)

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Each patient was given a serial number from a computer‐generated randomisation table"
Allocation concealment (selection bias) Low risk Quote: "Group allocations (Anodal, Cathodal, or Sham) were placed in serially numbered, opaque closed envelopes ... and each patient was placed in the appropriate group after opening the corresponding sealed envelope"
Blinding of participants and personnel (performance bias) 
 Subjective outcome measures Low risk Participants and therapists were blinded
Blinding of participants and personnel (performance bias) 
 Objective outcome measures Low risk Participants and therapists were blinded
Blinding of outcome assessment (detection bias) 
 Subjective outcome measures Low risk Outcome assessor was blinded
Blinding of outcome assessment (detection bias) 
 Objective outcome measures Low risk Outcome assessor was blinded
Incomplete outcome data (attrition bias) 
 Subjective outcome measures Low risk All randomised participants apparently completed the study. No treatment withdrawals, no losses to follow‐up, no trial group changes and no major adverse events were stated
Incomplete outcome data (attrition bias) 
 Objective outcome measures Low risk All randomised participants apparently completed the study. No treatment withdrawals, no losses to follow‐up, no trial group changes and no major adverse events were stated
Selective reporting (reporting bias) Low risk All outcomes stated in the study protocol and listed in the methods section of the publication have been reported